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Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Primary Purpose

ARDS, RDS, Surfactant

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

surfactant combined with mechanical ventilation (MV)

mechanical ventilation (MV)

About this trial

This is an interventional treatment trial for ARDS

Eligibility Criteria

30 Minutes - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

infant less than 28 days
diagnosis of ARDS or RDS or both
informed parental consent has been obtained

Exclusion Criteria:

major congenital malformations or complex congenital heart disease or chromosomal abnormalities
transferred out of the neonatal intensive care unit without treatment
upper respiratory tract abnormalities

Sites / Locations

Department of neonatology, Children's hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

surfactant combined with mechanical ventilation

mechanical ventilation

Arm Description

surfactant is given to the infant with ARDS.

mechanical ventilation is given to the infant with ARDS.

Outcomes

Primary Outcome Measures

death

neonates died

bronchopulmonary dysplasia(BPD)

neonates were diagnosed with BPD

BPD and/or death

neonates were diagnosed with BPD and/or death

Secondary Outcome Measures

Bayley Scales of Infant Development

the survival are assessed by Bayley Scales of Infant Development

haemodynamically significant patent ductusarteriosus (hsPDA)

neonates were diagnosed with hsPDA

retinopathy of prematurity (ROP)> 2nd stages

neonates were diagnosed with ROP> 2nd stages

necrotizing enterocolitis (NEC) ≥ 2nd stages

neonates were diagnosed with NEC ≥ 2nd stages

intraventricular hemorrhage(IVH)>2nd grades

neonates were diagnosed with IVH >2nd grades

Full Information

NCT ID

NCT03217162

First Posted

July 12, 2017

Last Updated

October 23, 2022

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03217162

Brief Title

Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Official Title

Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Detailed Description

To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth. According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS. Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ARDS, RDS, Surfactant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surfactant combined with mechanical ventilation

Arm Type

Experimental

Arm Description

surfactant is given to the infant with ARDS.

Arm Title

mechanical ventilation

Arm Type

Active Comparator

Arm Description

mechanical ventilation is given to the infant with ARDS.

Intervention Type

Drug

Intervention Name(s)

surfactant combined with mechanical ventilation (MV)

Intervention Description

surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS

Intervention Type

Drug

Intervention Name(s)

mechanical ventilation (MV)

Intervention Description

mechanical ventilation (MV) is given to the infant with ARDS

Primary Outcome Measure Information:

Title

death

Description

neonates died

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Title

bronchopulmonary dysplasia(BPD)

Description

neonates were diagnosed with BPD

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Title

BPD and/or death

Description

neonates were diagnosed with BPD and/or death

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Secondary Outcome Measure Information:

Title

Bayley Scales of Infant Development

Description

the survival are assessed by Bayley Scales of Infant Development

Time Frame

at 2 months old and 2 years old

Title

haemodynamically significant patent ductusarteriosus (hsPDA)

Description

neonates were diagnosed with hsPDA

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Title

retinopathy of prematurity (ROP)> 2nd stages

Description

neonates were diagnosed with ROP> 2nd stages

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Title

necrotizing enterocolitis (NEC) ≥ 2nd stages

Description

neonates were diagnosed with NEC ≥ 2nd stages

Time Frame

at 36 weeks' gestational age or before discharge from hospital

Title

intraventricular hemorrhage(IVH)>2nd grades

Description

neonates were diagnosed with IVH >2nd grades

Time Frame

at 36 weeks' gestational age or before discharge from hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Minutes

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: infant less than 28 days diagnosis of ARDS or RDS or both informed parental consent has been obtained Exclusion Criteria: major congenital malformations or complex congenital heart disease or chromosomal abnormalities transferred out of the neonatal intensive care unit without treatment upper respiratory tract abnormalities

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ma Juan, MD

Phone

13883559467

476679422@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ma Juan, MD

Phone

1388.559467

476679422@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shi Yuan, PhD,MD

Organizational Affiliation

Children's Hospital of Chongqing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Department of neonatology, Children's hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400014

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Ma, physician

Phone

18680887330

zoe330@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

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